NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04955730

Enrollment

290

Registered

2021-07-09

Start date

2021-08-05

Completion date

2025-09-23

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Infection

Brief summary

This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections

Interventions

DEVICENegative Pressure Wound Therapy

Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Participants, investigators and statisticians will be blinded to treatment randomization. Surgical oncologists will be blinded of treatment randomization until the dressing is applied to the wound.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Scheduled surgical procedure for the management of gastrointestinal cancer * Scheduled surgical procedure planned for incision that will result in wound \>5cm * Scheduled surgical procedure planned for skin wound that will be closed by primary intention with either: Staples covered by sterile Telfa® and Tegaderm® or Medipore® OR Dermal or subcuticular sutures covered by Octil® * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion criteria

* Scheduled surgical procedure where wound considered dirty * Scheduled surgical procedure for wound left for closure by secondary intention * Emergency surgery * Pregnancy. Pregnancy status is confirmed per protocol the day of surgery in the preoperative space by urine pregnancy test in patient younger than 65 and with intact uterus. Pregnant patient will be excluded from this study * History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate in the study or the inability to obtain informed consent because of psychiatric or complicating medical problems

Design outcomes

Primary

Measure	Time frame	Description
Surgical Site Infection - Superficial Incisional	30 days post operation	Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Superficial Incisions.
Surgical Site Infection - Deep Incisional	30 days post operation	Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Deep Incisions.
Surgical Site Infection - Organ/Space Incisional	30 days post operation	Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Organ/Space Incisions.

Secondary

Measure	Time frame	Description
Return to Intended Oncologic Therapy (RIOT)	Up to 12 months after surgery	Investigators will measure number of participants who returned to their intended oncologic therapy
Time to Initiation of Planned Oncologic Therapy	Up to 12 months after surgery	Investigators will measure time to initiation planned therapy from the surgery date to initiation date of planned oncologic therapy

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJose M Pimiento, MD

Moffitt Cancer Center

PRINCIPAL_INVESTIGATORDaniel Anaya, MD